ROCKVILLE, Md. – The U.S. Pharmacopeia (USP) has published its Annual Drug Shortages Report, which shows that long-standing, persistent shortages account for more than 90% of all drug shortages in the United States. The average duration of current shortages has risen to over four years, up from roughly three years in 2023.
“For patients, drug shortages can raise the risk of medication errors, treatment delays and higher out-of-pocket costs,” said Anthony Lakavage, senior vice president for Global External Affairs at USP. “Shortages also disrupt daily operations for healthcare professionals and contribute to higher costs for health systems. Industry and policymakers need end-to-end data and visibility to build a more reliable supply chain that works for everyone.”
Drugs typically enter and remain in shortage due to interrelated risk factors, including low prices paid to manufacturers, geographic concentration of production, manufacturing complexity, and quality inspection issues. These risk factors can be exacerbated by external shocks like natural disasters, geopolitical tension, or policy changes.
Persistent shortages, defined as those lasting for at least one year, can stem from unique or severe combinations of these risk factors. Sterile injectable drugs, for example, are particularly complex to manufacture and make up 69% of all shortages, the largest of any dosage form.
More than 40 medicines have been in shortage for over three years, and five of those have been in shortage for 10 or more years. The five most persistent shortages all are injectable medicines: atropine sulfate, fentanyl citrate, leucovorin calcium, lidocaine hydrochloride, and epinephrine bitartrate. These drugs are all used in pediatric care, including for anesthesia, pain management, and oncology treatments.
Lower-priced drugs also face a higher risk of shortage. This risk factor measures price as that paid to the manufacturer, not the price paid by patients or insurers. Nearly one-third of oral solid medicines in shortage are priced below $1 per unit, while 44% of injectables in shortage are priced below $5 per unit. Manufacturers often discontinue drug production when unfavorable market conditions, such as low profit margins, reduce incentives to remain in or enter the market. In 2024, 46% of discontinued oral solid drug products had a price point below $1 per unit.
“Manufacturers of generic drugs already face razor-thin margins,” said Vimala Raghavendran, vice president for Informatics Product Development at USP. “Purchasing contracts often reward low prices above all else. Without sustainable pricing and procurement models, it’s challenging for manufacturers to invest in quality, resilience, and innovation.”
Because fewer new shortages emerged during the year, total U.S. shortages declined from 125 in 2023 to 98 in 2024. While no one therapeutic class of drugs disproportionately experienced new shortages in 2024, five of the new shortages were sterile injectable medicines. Three of those five were caused by disruptions related to Hurricane Helene.
USP supports market and policy solutions to help mitigate, prevent and alleviate drug shortages by incentivizing supply chain resilience. USP also continues to publish insights from its Medicine Supply Map to inform efforts to strengthen the supply chain. Further data and insights will be released in the coming months.
